Customed Polyreinforced Surgical Gowns Recalled for Sterilization Validation Issues
Customed, Inc. is recalling polyreinforced surgical gowns due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the hazard is the potential failure of sterilization, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling polyreinforced surgical gowns (Code 900521) that were distributed in Puerto Rico. The recall involves 12,456 units of the product, which is used by medical staff for surgical procedures and patient care tasks such as wound healing and suture removals.
The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released for distribution as sterile. Specific lot numbers and expiration dates are listed in the official recall documentation.
Healthcare facilities and consumers who have these gowns should stop using them and contact the manufacturer or the FDA for further instructions on how to return or dispose of the product.
The recalled product
- Product
- GOWN POLYREINF XLGE TOWEL/W 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Gowns
- Affected units
- 12,456
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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